NCT07041437尚未招募2 期
Efficacy and Safety Study of SHR-A2102-based Treatment in Advanced Breast Cancer
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 48
- 试验地点
- 1
- 主要终点
- ORR by investigator
研究概览
简要总结
Our study is aimed to evaluate the efficacy and safety of SHR-A2102 combined other antitumor treatments in advanced breast cancer.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 years to 75 years old (including boundary values), patients with advanced or metastatic breast cancer;
- •ECOG PS Score: 0~1;
- •Based on RECIST v1.1, at least one measurable lesion;
- •Patients must have a life expectancy ≥ 3 months;
- •Adequate organ function and marrow function (no corrective treatment within 14 days before first dose);
- •Women of childbearing potential (WOCBP) should agree to use an effective method of contraception and no lactation from the initiation of screening to 7 months after the last dose of study therapy; WOCBP should have a negative serum pregnancy result within 7 days before the first dose of study therapy; if unneutered male subjects (including using other sterilization except bilateral orchidectomy [e.g. vasectomy]) are willing to have sexual behaviour with WOCBP, one kind of contraception must be used to prevent the pregnancy of his partner from the date of enrolment to 7 months after the last dose of study therapy);
- •Willing and able to provide written informed consent and comply with the requirements and restrictions in the protocol.
排除标准
- •Active brain metastasis; Stable brain metastasis (at least 4 weeks after intracranial local treatment, subjects should meet one of the following requirements: a. no signs of disease progression confirmed by imaging; b. no clinical symptom, and not necessary to corticosteroid or anticonvulsant therapy; c. with clinical symptom, but not necessary to increase dose of corticosteroid or combine with dexamethasone to control clinical symptom compared with intracranial local treatment) is allowed to be enrolled;
- •Existence of third space fluid (e.g. massive ascites, pleural effusion, pericardial effusion which needs drainage again to relieve symptoms within 4 weeks after the first drainage) which is not well controlled by effective methods, e.g. drainage;
- •Other malignancy within prior 2 years with no necessary treatment (except hormone replacement treatment) for at least recent 2 years, except: curatively treated in situ cancer of the cervix, skin basal cell carcinoma, skin squamous cell carcinoma or papillary thyroid carcinoma;
- •Has received antitumor surgery, radiotherapy, chemotherapy, targeted therapy or immunological therapy within 4 weeks before first dose of study therapy; has received antitumor endocrine therapy within one week before first dose of study therapy;
- •Adverse events caused by prior antitumor therapy have not recovered to ≤grade 1 per NCI-CTCAE v5.0 (except alopecia and tolerable, chronic grade 2 toxicity determined by investigator);
- •Use of other antitumor systemic treatment during the study;
- •Has received CYP3A4, CYP2D6, P-gp or BCRP potent inhibitors or inducers <5-fold half-life of the drug before the first dose;
- •Hypersensitivity to study therapy or any of its excipients;
- •Has known clinically significant lung disease, including but not limited to: interstitial lung disease, pneumonitis, pulmonary fibrosis;
- •Known history of immunodeficiency, including HIV-positive, other acquired or innate immunodeficient disease, or known history of organ transplantation, or known history of allogenic haemopoietic stem cell transplantation;
- •Has active hepatitis B (HBsAg-positive and HBV DNA≥500 IU/mL), hepatitis C (positive for HCV antibody and HCV RNA above ULN) and hepatic cirrhosis;
- •Has an active infection requiring antibiotics, antiviral or antifungal treatment, or pyrexia >38.5℃ of unknown origin during the screening period before first dose of study therapy (patients with pyrexia due to cancer could be enrolled determined by investigator);
- •Known severe cardiac-cerebral vascular disease, including but not limited to: a) known severe cardiac rhythm or conduction disorder, such as ventricular arrhythmias necessary for clinical intervention, second or third degree atrioventricular block; b) under the resting state, QTcF>470ms for female or 450ms for male examined by 12-lead ECG; c) acute coronary syndrome, congestive heart failure (NYHA classification of heart failure ≥ Class II), myocardial infarction, aortic dissection, cerebral stroke, or other ≥grade 3 cardiac-cerebral vascular events; d) LVEF<50%; e) clinically uncontrolled hypertension;
- •Existence of arterial/venous thrombotic event within 6 months before first dose, such as cerebrovascular accidents (including transient ischemic attack, cerebral haemorrhage and cerebral infarction), deep venous thrombosis and pulmonary embolism;
- •(Arm 2 only) Has received or been receiving PD-1/PD-L1 inhibitor;
- •(Arm 2 only) Has active autoimmune disease or a history of autoimmune disease (including but not limited to: autoimmune hepatitis, uveitis, inflammatory bowel disease, hypophysitis, vasculitis, nephritis, hyperthyroidism, uncontrolled hypothyroidism only treated with hormone replacement therapy); subject that has skin disease unnecessary for systemic treatment (such as vitiligo, psoriasis, alopecia), controlled type I diabetes treated with insulin, or complete remission of asthma in childhood and no need to any intervention in adulthood can be enrolled; subject that has asthma which needs medical intervention by bronchodilators can not be enrolled; subject that has been receiving chronic, systemic steroid therapy (daily dose >10mg prednisone or equivalent) or any other type of immunosuppressants within 2 weeks before the first dose of study therapy;
- •(Arm 2 only) Has received a live vaccine within 4 weeks before first dose of study therapy, or potential to receive a live vaccine during the trial treatment;
- •Other conditions that might influence the study and analysis of results in the opinion of the investigator.
研究组 & 干预措施
SHR-A2102
Experimental
Single Agent
干预措施: SHR-A2102 (Drug)
SHR-A2102+adebrelimab
Experimental
SHR-A2102 combined with adebrelimab
干预措施: SHR-A2102 (Drug)
SHR-A2102+adebrelimab
Experimental
SHR-A2102 combined with adebrelimab
干预措施: Adebrelimab (Drug)
结局指标
主要结局
ORR by investigator
时间窗: At baseline, at the time point of every 6 weeks
ORR is the percentage of evaluable patients with a confirmed investigator-assessed response of CR (complete response) or PR (partial response) per RECIST v1.1 and will be evaluated at baseline, at the time point of every 6 weeks.
次要结局
- DCR by investigator(At baseline, at the time point of every 6 weeks)
- DoR(up to 2 years)
- PFS(up to 2 years)
- OS(up to 2 years)
- Percentage of participants who experience an adverse event [Safety and Tolerability](From time of informed consent provided to 3 months after the last dose of study therapy)
研究者
Hongxia Wang
Chief physician
Fudan University
研究点 (1)
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